FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government shutdown goes into ef...
FDA posts a draft guidance to help drugmakers design clinical trials for treatments targeting disseminated coccidioidomycosis, also known as Valley Fe...
Larimar Therapeutics reports encouraging long-term data from its open-label study of nomlabofusp, an investigational therapy for Friedreichs ataxia.
Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.
FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed Phase 3 trial in adva...
FDA expands its medical device Early Alert program to cover all products that may pose significant safety risks.
CDER director George Tidmarsh urges more compliance with clinical trial reporting requirements through the Clinicaltrials.gov gateway.
AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.
